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FDA 510(k)

Posterior Cervical Spine System

K-Number: K233078 · 2023-11-22

ApplicantDouble Medical Technology, Inc.
Decision Date2023-11-22
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Posterior Cervical Spine System is the device name listed in this FDA 510(k) record. The listed applicant is Double Medical Technology, Inc.. It received FDA 510(k) clearance on 2023-11-22 under 510(k) number K233078. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Posterior Cervical Spine System?

Posterior Cervical Spine System is a medical device that received FDA 510(k) clearance on 2023-11-22. The listed applicant is Double Medical Technology, Inc.. The 510(k) number is K233078.

When did Posterior Cervical Spine System receive FDA 510(k) clearance?

Posterior Cervical Spine System received FDA 510(k) clearance on 2023-11-22, under 510(k) number K233078.

Who is the listed applicant for Posterior Cervical Spine System?

The FDA 510(k) record lists Double Medical Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Posterior Cervical Spine System?

The FDA product code for Posterior Cervical Spine System is NKG.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07606729AI-Driven Programs for Non-specific Chronic Neck PainACTIVE_NOT_RECRUITINGNCT07739979Radiological Outcome of Bony Fusion After Single Level Anterior Cervical Discectomy and Fusion Using Iliac Crest Graft vs. Polyetheretherketone Cage in Cervical SpondylosisCOMPLETEDNCT07789288Hard Cervical Collar Use Following Posterior Cervical FusionRECRUITING

Other records listing Double Medical Technology, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252729Universal Spinal SystemK242348Locking Screw,CoCrMoK223753Cervical Plate SystemK221150Advanced Bone PlateK221088Anatomic Bone PlateK221090Metal Cannulated Screw

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Related Devices (Code: NKG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemCarboFix Orthopedics , Ltd.K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AGK253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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